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Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

NCT ID: NCT00241319

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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R89674 (generic name not yet established)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* history of ocular allergies and a positive skin test reaction to cat hair,
* cat dander, grasses, ragweed, and/or trees within the past 24 months;
* calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction

Exclusion Criteria

* narrow angle glaucoma,
* clinically significant blepharitis, follicular conjunctivitis, iritis
* pterygium or diagnosis of dry eye
* ocular surgical intervention within 3 months
* history of refractive surgery within 6 months
* known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
* presence of active ocular infection positive history of an ocular herpetic infection
* preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vistakon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingerman Avner, MD

Role: STUDY_DIRECTOR

Johnson & Johnson

Locations

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Indianapolis, Indiana, United States

Site Status

Lewiston, Maine, United States

Site Status

Rochester, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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05-003-11

Identifier Type: -

Identifier Source: org_study_id